Compound danshen dripping pills (CSDP) are believed to be a new generation of medicine for treating cardiovascular diseases, exclusively provided by Tasly Pharmaceutical Group Co., Ltd. The CSDP is made from Traditional Chinese Medicines (TCMs) of Radix Salvia Miltiorrhira acting as monarch drug, Panax Notoginseng as minister drug and borneol as adjuvant drug, having the efficacy of removing stasis by circulating blood, relieving pain by freeing Bi and inducing resuscitation with herbal aromatics. Clinically, it has been used mainly for treating cardiovascular diseases. At present, the CSDP commercially available in Chinese market is packaged in high density polyethylene (HDPE) medicine bottle with the specifications of 180 pills/bottle, 150 pills/bottle, 100 pills/bottle and 60 pills/bottle. When used each time, 10 dripping pills are taken out from the bottle for oral administration. However, it is difficult for the patients out of China to accept this way of taking the CSDP. In order to enter the international market, the applicant planed to further develop the present CSDP into the CSDP capsule.
As an edible packaging material for food and drug, the capsule shells with different properties can produce influence upon the stability of food and drug to a certain degree. At present, the commercially available capsule shells are usually divided into two types: the gelatine capsule shell and the plant-derived capsule shell.
In terms of source, the gelatine capsule shell is mainly manufactured from collagen, a kind of protein derived from animal skin, bone and tendon purified by partial hydrolysis, and therefore a great deal of purine is contained. Fish gelatin capsule shell is a new type of gelatin capsule shell developed in recent years.
Further, the plant-derived capsule shell is mainly derived from plants, e.g. by using hydroxypropyl methyl cellulose (HPMC) as the raw material, and the raw material contains polysaccharide and the basic components of plant cell wall. At present, the common plant-derived capsule shells include as follows: the plant-derived capsule shell made from pullulan, the plant-derived capsule shell made from marine algal polysaccharide and the plant-derived capsule shell made from HPMC.
Practically, the transparent capsule shell can easily enhance the interest of using TCM, because it directly improves consumers' sensory understanding. Thus, it can be expected that the transparent capsule shell will make the TCM win the massive popularity worldwide. However, the transparent capsule shells with different colors can reflect lights at different wavelength, rendering the capsule content to be exposed to the lights having different wave energy. As a result, the transparent capsule shells with the different colors can potentially have an effect on the stability of the content to a certain extent. Likewise, the capsule shells made of different materials produce different influence on the stability of drug content because of the difference in their own hygroscopicity, stability and physicochemical properties.
In order to better achieve optimal protection for the drug content, after longtime research on the effect of capsule shells made of different materials with different colors on stability of capsules' content, the inventors of the present invention had explored and optimized some kinds of capsule shell benefiting the stability of capsules' content.